Delivery Catheter System With Micro and Macro Movement Control

ABSTRACT

A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/485,434, filed May 12, 2011, andU.S. Provisional Patent Application No. 61/485,455 filed May 12, 2011,which are incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates generally to devices and methods forrepair The present invention relates to a delivery system forpositioning and deploying a prosthetic heart valve, in particular anaortic heart valve. More specifically, the present invention is directedto aspects of providing the delivery system for use by a surgeon and ofcontrolling the delivery and deployment of such a prosthetic heartvalve.

BACKGROUND

Recently, there has been interest in minimally invasive and percutaneousreplacement of cardiac valves. In the specific context of pulmonaryvalve replacement, for example, U.S. Patent Application Publication Nos.2003/0199971 A1 and 2003/0199963 A1, both filed by Tower, et al. andincorporated herein by reference, describe a valved segment of bovinejugular vein, mounted within an expandable stent, for use as areplacement pulmonary valve. The replacement valve is mounted on aballoon catheter and delivered percutaneously via the vascular system tothe location of the failed pulmonary valve and expanded by the balloonto compress the native valve leaflets against the right ventricularoutflow tract, thereby anchoring and sealing the replacement valve.

As described in the articles: “Percutaneous Insertion of the PulmonaryValve”, Bonhoeffer, et al., Journal of the American College ofCardiology 2002; 39: 1664-1669 and “Transcatheter Replacement of aBovine Valve in Pulmonary Position”, Bonhoeffer, et al., Circulation2000; 102: 813-816, both incorporated herein by reference in theirentireties, the replacement pulmonary valve may be implanted to replacenative pulmonary valves or prosthetic pulmonary valves located in valvedconduits. Other articles that describe features of percutaneous valveimplantation include Louise Coats, et al., “The Potential Impact ofPercutaneous Pulmonary Valve Stent Implantation on Right VentricularOutflow Tract Re-Intervention,” European Journal of Cardio-ThoracicSurgery (England), April 2005, pgs. 536-43; Peter C. Block, et al.,“Percutaneous Approaches to Valvular Heard Disease,” Current CardiologyReports (United States), March 2005, pgs. 108-13; Georg Lutter, et al.,“Percutaneous Valve Replacement: Current State and Future Prospects,”Annals of Thoracic Surgery (Netherlands), December 2004, pgs. 2199-206;Younes Boudjemline, et al., “Percutaneous Pulmonary Valve Replacement ina Large Right Ventricular Outflow Tract: An Experimental Study,” Journalof the American College of Cardiology (United States), Mar. 17, 2004,pgs. 1082-7; S. Khambadkone, et al., “Percutaneous Implantation ofPulmonary Valves,” Expert Review of Cardiovascular Therapy (England),November 2003, pgs. 541-18; Y. Boudjemline, et al., “Percutaneous ValveInsertion: A New Approach,” Journal of Thoracic and CardiovascularSurgery (United States), March 2003, pgs. 741-2; Philipp Bonhoeffer, etal., “Percutaneous Insertion of the Pulmonary Valve,” Journal of theAmerican College of Cardiology (United States), May 15, 2002, pgs.1664-9; Younes Boudjemline, et al., “Steps Toward Percutaneous AorticValve Replacement,” Circulation (United States), Feb. 12, 2002, pgs.775-8; P. Bonhoeffer, et al., “Percutaneous Replacement of PulmonaryValve in a Right-Ventricle to Pulmonary-Artery Prosthetic Conduit withValve Dysfunction,” Lancet (England), Oct. 21, 2000, pgs 1403-5; P.Bonhoeffer, et al., “Transcatheter Implantation of a Bovine Valve inPulmonary Position: A Lamb Study,” Circulation (United States), Aug. 15,2000, pgs. 813-6; G. O. Yonga et al., “Effect of Percutaneous BalloonMitral Valvotomy on Pulmonary Venous Flow in Severe Mitral Stenosis,”East African Medical Journal (Kenya), January 1999, pgs. 28-30; and G.O. Yonga, et al., “Percutaneous Transluminal Balloon Valvuloplasty forPulmonary Valve Stenosis: Report on Six Cases,” East African MedicalJournal (Kenya), April 1994, pgs. 232-5, all of which are alsoincorporated herein by reference in their entireties.

The approach to pulmonary valve replacement described in the abovepatent applications and articles remains a viable treatment for certainpatients. In particular, the Melody valve is a commercial form of apulmonary valve replacement available from Medtronic, Inc. that isusable according to the above noted approach. Other techniques have alsobeen developed to broaden those patients that can benefit from suchpulmonary valve replacement procedures including the provision of othersize valves than those of sizes that can be created from the size rangeof available valved segments of bovine jugular veins.

A delivery system that is associated with the Melody pulmonary valve isalso commercially available from Medtronic, Inc. The Melody deliverysystem is a catheter system that includes an inflatable balloon at adistal end of the device onto which the pulmonary valve replacement iscrimped. This system is designed for control and steerability from aproximal end of the device for guiding the pulmonary valve replacementto position within a patient's heart via the patient's vasculature. Inparticular, this system is designed for deployment by the balloon at thepatient's native pulmonary valve annulus as accessed via the femoralvein of the patient. The valve is typically sheathed as crimped directlyonto the distal balloon of the delivery system and includes the abilityto slide the sheath from covering the collapsed replacement valve sothat the balloon can thereafter be expanded for permanently deformingand expanding the metal structure of the replacement valve into apermanent position at the pulmonary valve annulus.

Percutaneous aortic valve replacement procedures are also beinginvestigated. One such valve that has been successfully deployed from acatheter delivery system is the CoreValve aortic valve and system, thatis also available from Medtronic, Inc. The CoreValve aortic valvereplaces the aortic valve in patients with severe aortic stenosis. Thevalve leaflets are provided by utilizing a bovine pericardial valve thatis sutured to the expandable metal frame. This expandable metal frame,however, utilizes Nitinol metal allow so that the frame and thus theaortic valve is self-expanding for controlled deployment at the aorticvalve annulus. This frame structure is typically around 5 cm long and isshaped along its length with a non-uniform diameter for improvedanchoring of the aortic valve in position at the valve annulus. Furtherdisclosure of aspects of the CoreValve aortic valve and delivery systemare provided within U.S. Pat. Nos. 7,682,390, 7,780,726 and 7,892,281.

Delivery of the CoreValve aortic valve prosthesis or any otherpercutaneous and self-expandable aortic valve prosthesis typicallyrequires a movable sheath at the distal end of a delivery system thatmaintains a compressed valve prosthesis beneath the sheath. Retractionof the sheath in a proximal direction of the delivery system ascontrolled from the proximal end of the delivery system is controlledfor deploying the self-expandable valve prosthesis from one end thereofto another. Specifically, a distally positioned end of the valveprosthesis initially expands as the sheath is retracted while aproximally positioned end of the valve prosthesis remains collapsedwithin the confines of the sheath. A gradual expansion is thuscontrolled so that the full prosthetic valve is deployed in position,such as at a particular valve annulus. Typically, controlled expansionis conducted by maintaining the prosthetic valve as positioned on thedistal end of the delivery system at a precise position, such asdetermined by fluoroscopy, while sliding the sheath proximally relativeto the prosthetic valve and distal end of the delivery system.Self-expansion of the valve prosthesis deploys the prosthesis in thisprecise position and expansion of the metal frame of the prostheticvalve anchors the prosthetic valve in place. The sliding movement of thesheath can be conducted manually by a surgeon, for example, and suchmovement can be facilitated and controlled by mechanical meansincorporated within a handle at the proximal end of the delivery system.

One such delivery system that has been designed for delivery of aself-expanding valve prosthesis is the AccuTrak™ delivery system that iscommercially available from Medtronic, Inc. and is provided as a part ofa system including the CoreValve aortic valve prosthesis, discussedabove.

SUMMARY

The present invention overcomes shortcomings and deficiencies of priorart delivery systems by providing a prosthetic valve delivery systemthat is improved in controllability by way of a proximal handle system.Such a handle system of the present invention advantageously permits acontrolled fine or micro movement of a distal sheath for uncovering aprosthetic valve for deployment thereof, and also permits aquick-release for a gross or macro movement to the sheath. Also, apackaging tray of the present invention provides for effectiveprotective packaging along with storage and shipping ability, and alsoadvantageously provides for a preparation tray for a surgeon to use justprior to a surgical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a perspective view of a delivery system in accordance with thepresent invention including a control handle assembly that is providedat a proximal end of the delivery system for selectively controllingmovement of a prosthesis covering sheath at a distal end of the deliverysystem, which handle assembly controls both micro movement and aquick-release macro movement of the sheath, along with releasablecomponents of the delivery system in order to facilitate quicker andeasier delivery, system withdraw, and deployment of a prosthetic heartvalve;

FIG. 2 is a side view of the delivery system of FIG. 1 illustrating afront grip portion, a translating rotator portion including aquick-release button, a proximal hand rest portion, and a tip retractorportion.

FIG. 3 is a cross-sectional view of the delivery system of FIG. 2illustrating an internal screw shaft that is fixed with a plunger at adistal end of the delivery system by an inner tube and that isrelatively movable to an outer tube that is connected with a sheath atthe distal end of the delivery system so that the translating rotatormoves along the internal screw shaft to move the sheath relative to theplunger as the plunger is maintained at a desired deployment position;

FIG. 4 is an enlarged cross-sectional view of the plunger and sheathportion of the delivery system of the delivery system of FIG. 3;

FIG. 5 is a partially exploded view of the delivery system of FIGS. 1-4illustrating the manner of assembly of an inner shaft relative to anouter shaft and with respect to a stabilizing shaft and a flush tube;

FIG. 6 is an enlarged cross-sectional view of an assembly including theinternal screw shaft along with a drive tube that is internal to thescrew shaft, as such assembly is positioned within the front grip,translating rotor and proximal hand rest;

FIG. 7 is an enlarged cross-section of a quickly releasable tipretractor;

FIG. 8 is a partially exploded view of the delivery system of theprevious figures showing the control handle assembly components;

FIG. 9 is an enlarged cross-sectional view of a distal portion of thehandle assembly including a portion of the front grip and of theinternal screw shaft;

FIG. 10 is a top view of the handle assembly with the quick-releasebutton shown in a locked position along a slide;

FIG. 11 is top view of a packaging and preparation tray in accordancewith another aspect of the present invention including a proximalportion and a pivotal distal portion, the tray being illustrated withproximal and distal securing portions to the side of the main trayassembly and with a delivery system in accordance with the presentinvention also positioned within the main tray assembly;

FIG. 12 is a top view similar to FIG. 11, but with the proximal anddistal securing portions positioned over portions of the main trayassembly and holding a delivery system in accordance with the presentinvention in place;

FIG. 13 is a top view of the packaging and preparation tray of FIGS. 11and 12 but with the distal portion thereof pivoted to a positionadjacent to the proximal tray portion, which position is configured toallow preparation, such as on a sterile table surface, of the deliverysystem and loading a prosthetic heart valve device on the distal end ofthe delivery system within a controlled environment, such as temperaturecontrolled saline; and

FIG. 14 is a schematic view of another aspect of the present inventionincluding the provision of specifically coated portions of a deliverysystem to improve the insertion and withdrawal of the delivery systemwithin the vasculature of a patient and for controlled deployment of aheart valve prosthesis.

DETAILED DESCRIPTION

Referring now to the Figures, wherein the components are labelled withlike numerals throughout the several Figures, and initially to FIG. 1,an exemplary delivery system 10 is illustrated for percutaneousinsertion and implantation of a biological valvular replacement to adesired implant location, such as within a patient's heart. A prostheticheart valve can be delivered by delivery systems of the presentinvention as such prosthetic heart valves can be designed forreplacement of the aortic valve, mitral valve, tricuspid valve, orpulmonary valve by way of a patient's vasculature, such as includingaccess through a patient's femoral artery or femoral vein, or otherwise,as appropriate in accordance with known or developed delivery techniquesutilizing percutaneous delivery. Delivery systems according to thepresent invention improve the ease and accuracy of prosthetic valvedelivery through the vasculature and avoid deployment difficultiesrelated to the need to control the delivery and deployment actions atthe distal end of such a delivery system from a proximally providedcontrol handle.

Delivery system 10 is preferably used for delivering an expandable metalframe valve to a desired implant location, such as by way of, thefemoral artery, the femoral vein, the pulmonary vein, a valved conduit,or otherwise. One preferably expandable valve that is desired to bedelivered by the delivery system 10 of the present invention is theCoreValve aortic valve, as is commercially available from Medtronic,Inc., the assignee of the present invention, and as certain aspectsthereof are described within U.S. Pat. Nos. 7,682,390, 7,780,726 and7,892,281, the entire disclosures of which are incorporated herein byreference.

As shown in FIG. 1, delivery system 10 generally comprises a catheterportion 12, a distal deployment portion 14, and a proximal controlhandle portion 16 by which the deployment portion 14 is effectivelycontrolled. The catheter portion 12 is preferably of a length and sizeso as to permit a controlled delivery of the deployment portion 14 to adesired implant location of a patient's heart, for example. Preferably,the catheter portion 12 includes features to enhance maneuverability,steerability and advancement of the deployment portion 14 to the pointof implantation, as further discussed below. The deployment portion 14provides the means by which a metal frame prosthetic valve can bemounted for delivery to the implantation location and further providesfor allowing the expansion of the metal frame prosthetic valve foreffective deployment thereof. The control handle portion 16 preferablycontrols movements as translated to the deployment portion 14 by way ofelongate structure of the catheter portion 12. Controlled functionalityfrom the control handle portion 16 is preferably provided in order topermit expansion and deployment of a metal frame prosthetic valve at adesired location, such as a heart valve annulus, and to provide for easein the delivery and withdrawal of the delivery system through apatient's vasculature.

The catheter portion 12 comprises plural elongate elements preferablyincluding a flexible outer shaft 18 that is operatively connected withthe control handle portion 16 so as to be movable by operation of thehandle control portion, as described below, and that is connected with asheath 20. Movement of the sheath 20 proximally from its distalmostposition exposes a plunger 22 that is connected with an inner shaft 24.The inner shaft 24 is also operatively connected with the control handleportion 16, but so as to be relatively fixed with respect to the outershaft 18 and sheath 20. That way, relative movement of the outer shaft18 and sheath 20 with respect to the plunger 22 and inner shaft 24provides for a controlled covering or exposing of the plunger 22. Moreparticularly, when an expandable prosthetic heart valve is collapsedonto the plunger 22, withdrawing of the sheath 20 to expose theprosthetic valve as collapsed onto the plunger 22 provides forcontrolled expansion of the prosthetic valve and controlled deploymentthereof. Where the prosthetic valve comprises a metal frame valve thatis self expanding, the proximal movement of the sheath 20 allows themetal frame of the valve to expand for deployment of its valve leafletsin position as located by delivery system 10.

With reference to FIG. 4, in particular, the sheath 20 is illustrated ata distalmost or closed position with a leading edge thereof abuttingagainst a perimetric shoulder 26 of a nosecone 28 that is provided asthe leading feature of the plunger 22. Proximally from the nosecone 28,the plunger 22 comprises a reduced diameter portion 30 onto which anexpandable prosthetic heart valve is to be collapsed. At theproximal-most end of the plunger 22, a increased diameter portion 32defines a proximal edge for positioning the collapsed valve distally andalso provides a connection point for connecting the plunger 22 to thedistal end of the inner shaft 24. A lumen 34 passing axially through theplunger 22 also preferably aligns with a lumen 36 of the inner shaft 24as these components are fixed together to provide a continuous lumen.

A flush tube 38 is provided that preferably extends within the innershaft 24 passing through the lumen 36. Fluid communication and transportis provided by appropriate passage throughout the system. Orifices arealso provided, as needed, for fluid to pass out of the delivery systemfor flushing or other purposes. The flush tube 38 also preferablyincludes an axial lumen extending entirely though it, the purpose ofwhich is for receiving a guide wire, as well known, in order for thedelivery system 10 to be guided along a patient's vasculature to animplant location. The guide wire, not shown, may be, for example, a0.089 cm extra stiff guidewire as manufactured by Amplatzer of GoldenValley, Minn., and be used in a conventional manner to guide thedelivery system along it and with its distal end guided to its desiredimplant location.

The catheter portion 12 of the delivery system 10 also preferablycomprises a stability shaft 48 that is also operatively connected with adistal end of the control handle portion 16 and that surrounds the outershaft 18 over at least a part of its length. Preferably, the stabilityshaft comprises a braided stainless steel inner layer with a flexibleplastic outer layer. Such a stability layer facilitates the advancementand steering of the delivery system along a guide wire and through apatient's vasculature by improving the pushability of the deliverysystem 10, improving torque transmission to the tip of the deliverysystem 10 for steerability, and by preventing kinking along the catheterportion 12 of the delivery system

The control handle portion 16 is designed, among other things, forcontrolling the covering and the withdrawal of the sheath 20 withrespect to the plunger 22, and further with respect to an expandableprosthetic heart valve as such can be collapsed onto the plunger 22, asdescribed above. With reference to FIGS. 2 and 3, in particular, thecontrol handle portion 16 comprises a front grip 50, a micro-controlactuator 52, and a carriage 54 as those elements that are grasped andmanipulated by a surgeon during a procedure according to the presentinvention for controlling the covering and withdrawing of the sheath 20relative to the plunger 22. This functionality is achieved by a relativemovement between the front grip 50 and the micro-control actuator 52, asthe micro-control actuator 52 is operatively connected with the outershaft 18. Specifically, the micro-control actuator 52 and the carriage54 can translate together along a screw shaft 56 that is fixed with thefront grip 50.

As shown in FIG. 6, the screw shaft 56 includes a distal portion 58 thatfits within and is fixed to the front grip 50. More proximally, thescrew shaft increases in diameter to an elongate threaded portion 60that extends at least through the axial distance of the micro-controlactuator 52. Proximally of the threaded portion 60, a non-threadedportion 62 extends along which the carriage 54 can translate. Themicro-control actuator 52 preferably translates along the screw shaft 56by rotation thereof in the manner of a nut moving along a threadedshaft. The carriage 54 is preferably axially movable along the screwshaft 56 without rotating as the carriage 54 is driven by themicro-control actuator 52. As illustrated, the screw shaft 56 includes apair of diametrically opposed slots 64 that extend over a proximalportion of the threaded portion 60 of the screw shaft. Pins 66 areprovided inward from the carriage 54 and to extend into the slots 64.This arrangement allows the carriage 54 to translate along the screwshaft 56 without rotating. The carriage 54 is also preferably axiallyconnected to the micro-control actuator 52 such as shown at 68, wherebyan inner annular flange 70 of the carriage 56 fits within an outerannular flange 72 of the micro-control actuator 52. This arrangementallows the micro-control actuator 52 to rotate relative to the carriage56, but to be axially movable together.

In order to functionally connect the outer shaft 18 so as to translatewith the micro-control actuator 52, a T-shaft 74 is movably providedwithin an internal axial passage 76 of the screw shaft 56. The slots 64also are open into the internal axial passage 76. The T-shaft 74comprises a rod portion 78 and a pair of tabs 80 that are provided toextent through the slots 64 of the screw shaft 56 and to fit within anannular recess 82 of the internal side of the micro-control actuator 52.Preferably, the tabs 80 fit closely within the annular recess 82 so thatthere is a direct movement of the T-shaft 74 in the axial direction asthe micro-control actuator 52 moves axially along the screw shaft 56when rotated. This length of the slots 64 define the range of travel ofthe T-shaft 74 and thus the micro-control actuator 52 along the screwshaft 56. The rotation is not transmitted to the T-shaft 74 as theinteraction of the tabs 80 and slots 64 prevent rotation of the T-shaftrelative to the screw shaft 56.

The T-shaft is also operatively fixed with the outer shaft 18 for movingthe outer shaft and thus the sheath 20 under the control of themicro-control actuator 52. The proximal end of the outer shaft 16 ispreferably provided to extend within a lumen 83 of the T-shaft. Theouter tube and be bonded to the lumen 83 of the T-shaft anywhere alongcontacting surfaces of the length of contact as desired. As a result ofthis arrangement, axial movement of the T-shaft 56 as controlled by themicro-control actuator 52 is directly translated to the outer shaft 18and thus the sheath 20.

In accordance with another aspect of the present invention, the controlhandle portion 16 includes a macro-actuation ability. Between themicro-control actuator 52 and the screw shaft 56, a threaded insertassembly 78 is provided, as shown in FIGS. 6 and 8, that functions toreleasably engage with the threaded portion 60 of the screw shaft 56.Female threads of the insert assembly 78 releasably engage with the malethreads of the treaded portion 60 so that when they are engaged,rotation of the micro-control actuator 52 causes translation of themicro-control actuator 52 along the screw shaft 56. When released, themicro-control actuator 52 is permitted to freely slide along the screwshaft 56 without rotation along a range of movement that is preferablysufficient to completely cover or uncover the valve support reduceddiameter portion 30 of the plunger 22 by the sheath 20. This selectiverelease is preferably controlled by sliding a release trigger 80, asshown also in FIG. 10, that is movable along a slot 82 of themicro-control actuator 52.

The threaded insert assembly 78, as illustrated, comprises an innersleeve 84 that rides along the threaded portion 60 of the screw shaft 56and that includes a pair of diametrically opposed flexible tabs 86 thatare each provided with a threaded surface to engage with the threads ofthe threaded portion 60 when urged toward the screw shaft 56. Theremainder of the inside surface of the inner sleeve 84 is non-threadedto simply slide along the threaded portion 60. The tabs 86 can be formedwith the inner sleeve 84 and can be hingedly connected so as to bebiased radially outward or away from the threaded portion 60. When thetabs 86 are permitted to move freely, the tabs 86 do not threadinglyengage with the threaded portion 60, as they are biased outwardly, sothat the sleeve 84, and thus the threaded insert assembly 78 can freelymove along the screw shaft 56, as described above.

In order to engage the threads of the tabs 86 with the threaded portion60 and to engage the micro-control actuator 52 for micro-control of thesheath 20, an outer sleeve 88 can be provided, as illustrated, thatslides along an outer surface of the inner sleeve 84. A compressionspring 90 is also preferably provided along the outer surface of theinner sleeve 84, and is illustrated to bias the outer sleeve 88distally. Spring 90 is shown as engaged with a proximal end of the outersleeve 88 and with an annular flange 92 that is provided at a proximalend of the inner sleeve 84. A distal annular flange 94 of the innersleeve provides a stop for movement of the outer sleeve 88 distally. Assuch, the outer sleeve 88 of this preferred embodiment of a quickrelease assembly to permit macro-control can move along the surface ofthe inner sleeve 84 under the distal bias of the spring 90. In thedistal-most position of the outer sleeve 88, the tabs 86 are forcedagainst their outward bias to be positioned radially inwardly and withthe female threads of the tabs 86 engaged with the male threads of thethreaded portion 60 of the screw shaft 56. That is, with the outersleeve 88 in its distal-most position, the micro-control actuator 52 iseffectively engaged for micro-control of movement of the sheath 20.

The outer sleeve 88 is preferably connected with the release trigger 80so as to be movable with the trigger 80 along the range of movement thatis permitted by the length of the slot 82. That way, sliding the trigger80 proximally against the bias of the spring 90 moves the outer sleeve88 proximally. After sufficient movement of the outer sleeve 88, thetabs 86 are released from engagement with the inner surface of the outersleeve 88 and the tabs 86 move radially outward with their threads movedout of engagement with the threaded portion 60 of the screw shaft 56.Macro-adjustment of the sheath 20 is thus possible with the triggermoved sufficiently proximally. Release of the trigger 80 allows spring90 to move the outer sleeve 88 distally, which action forces the tabs 86radially inwardly into engagement with the threaded portion 60 of thescrew shaft 56 and activates the micro-control of the sheath 20 by themicro-control actuator 52.

At the proximal end of the delivery system 10, a tip retractor 96 isprovided that is releasably connected with the delivery system 10.Preferably, the tip retractor 96 is attached to the proximal end of theinner shaft 24 so that when the tip retractor 96 is disconnected fromthe delivery system 10, as described below, the inner shaft 24 and theplunger 22 can be pulled proximally up to the point of engagementbetween the shoulder 26 of the nosecone 28 and the leading edge of thesheath 20. As will be more apparent with the operational descriptionbelow, the greatest degree of proximal movement of the nosecone 28 tothe leading edge of the sheath 20 as a result of disconnecting the tipretractor 96 will be when the micro-control actuator 52 is translated toits proximal-most position. Once the micro-control actuator 52 isrotated so that the micro-control actuator 52 is fully proximally moved,the sheath 20 assumes its fully withdrawn position relative to theplunger 22, and to a prosthetic heart valve device when supportedthereon. If at this point, the trigger 80 is moved proximally, themicro-control actuator 52 can be quickly slid along the screw shaft 56to its distal-most position and the sheath 20 will be moved distallyfully forward to cover the plunger and engage the nosecone 28. However,if the micro-control actuator 52 is left at the proximal-most position,or at any position that is proximal from the distal-most position of themicro-control actuator 52, the tip retractor 96 can be disconnected fromthe delivery system and the plunger pulled proximally by way of theinner shaft 24 until the nosecone 28 abuts with the leading edge of thesheath 20.

In order to provide the quick disconnect between the tip retractor 96and the remainder of the delivery system 10, an adapter 98 is providedthat is connected to prevent axial movement or rotation to the proximalend of portion 62 of the screw shaft 56. The adapter 96 is preferablyreduced in diameter to fit within a passage of the tip retractor andincludes an annular recess 99. Spring loaded push buttons 100 are alsopreferably slidably supported along openings of the tip retractor 96 andbiased with engagement portions 102 thereof fitted into the annularrecess 99. That way, pushing both the buttons 100 inward causes arelease of each of the engagement elements thereof from the annularrecess 99 and thus a disconnection of the tip retractor 96 from theadapter 98, in particular, of the delivery system 10.

Also preferably incorporated within the tip retractor 96 is a flush tubehub 104 so that the flush tube 38 can pass through the delivery systemproximally. The flush tube hub 104 also provides for the ability toprovide fluids throughout and from the delivery system as needed.

Additionally, a flush port 106 is preferably provided at the distal endof the front grip 50 with reference to FIG. 9. An access passage 108 ofa hub 110 at the distal end of the front grip 50 provides for fluid flowfrom the flush port. FIG. 9 also illustrates the preferred provision ofa strain relief element 110 and a manner of connection of the stabilityshaft 48 to the hub 110 at the distal end of the front grip 50.Insertion of the stability shaft 48 partially into the hub 110 positionsthe end of the stability shaft 48, and a bond is preferably made betweenthe stability shaft 48 and the hub 110.

Another aspect of the present invention resides within the shaping,sizing and positioning of the control handle portion 16 of the deliverysystem 10. Specifically, the front grip 50, micro-control actuator 52,and carriage 54 are positioned in that order going proximally from thedistal end of the front grip so that when the micro-control actuator 52is fully distally positioned, and as the carriage 54 is positionedaxially adjacent to the micro-control actuator 52 by it axial connectionthereto, a smooth contoured outer surface profile is created along withthe front grip 50. In use, as described more below, the control handleportion 16 is typically gripped at the front grip 50 by the left hand(assuming a right handed surgeon). The surgeon's right hand is theneasily positionable partially on the carriage 64 and partially on themicro-control actuator 52. The right palm would rest on the contouredsurface of the carriage 54 while the right fingers could be positionedfor manipulation of the micro-control actuator 52. The right thumb andfirst couple fingers can grasp and rotate the micro-control actuator 52from this position, and the right thumb is positioned for easy slidingof the trigger 80 when desired.

Preferably, the front grip 50 is contoured with a curved outer surfacecreating an outward bulge to facilitate the surgeon's hand similar to abicycle grip. The Carriage 54 is preferably sloped away from themicro-control actuator 52 to provide a palm rest. The micro-controlactuator 52 is preferably contoured with an inward curve between outercurves, each of which outer curves tend to curve back to the level ofthe surface of the adjacent surfaces of the front grip 50 and thecarriage 54, respectively. The inward curve provides a gripping zone forthe surgeon's thumb and forefinger to affect easy rotation of themicro-control actuator 52. Overall, the profile from the leading ordistal end of the control handle portion 16 to the trailing or proximalend of the control handle portion 16 is preferably a series of smoothcontours including curves that facilitate easy gripping and manipulationof the control handle features, as discussed above.

An additional aspect of the present invention relates to a manner ofpackaging a delivery system 10 of the present invention for ease inproviding all the necessary elements of the delivery system 10 to allowfor storage until needed, and to facilitate quick and easy removal andset up of the delivery system with a prosthetic heart valve for use in asurgery by a surgeon at the time of the operation.

A packaging and preparation tray assembly 500 is illustrated in FIG. 11.The packaging and preparation tray assembly 500, as illustrated,comprises a first main tray 502 for supporting a proximal portion of adelivery system 10 in accordance with the present invention and apivotal second main tray 504 for supporting a distal portion of such adelivery system 10. The tray assembly 500 is illustrated as alsoincluding first and second securing trays 506 and 508 that are shown aspositioned to the side of the first and second main trays of the trayassembly 500 and with a delivery system 10 in accordance with thepresent invention also positioned within the tray assembly 500.

The first main tray 502 preferably is formed to provide supportingfeatures that are based upon the shape and dimensions of a deliverysystem 10 of the present invention. Preferably, the first main tray 502is formed to support about half the length of the delivery system 10,such as including the handle control portion 16 and a part of thecatheter portion 12, as such portions are described above. The secondmain tray 504 also preferably supports about half of the delivery system10, such as including part of the catheter portion 12, and thedeployment portion 14, as such terms are also described above.

The first and second main trays 502 and 504 are preferably formed withsupports that are shaped to correspond with portions of the deliverysystem 10 along its length so as to keep the delivery system 10 in placeas packaged. Such formed support structures are well known withinplastic molding and forming technologies for packaging. As illustrated,the first main tray 502 can also include similarly formed support shapesfor a prosthetic heart valve 510, such as conventionally provided withina sealed container, and a loading funnel 512 and adapter 514, as areused in the loading process of the valve 510 onto the delivery system10, as discussed further below. The second main tray 504 is illustratedas formed to facilitate the elongate catheter portion 12 and deploymentportion 14 as extended linearly from the first main tray 502. That is,the catheter portion 12 and thus the delivery system 10 can be linearlyarranged without bending as packaged within the tray assembly 500 byhaving the first and second main trays 502 and 504 arranged end to end.

FIG. 11 shows the tray assembly 500 with securing trays 506 and 508 notpositioned over and covering portions of the delivery system 10, as suchis illustrated in covered positions in FIG. 12. Securing tray 506 isshown attached to first main tray 502 by a pair of flexible hinge straps516. These straps 516 allow the securing tray 506 to be folded over thefirst main tray 502 so that the securing tray 506, which is sized andformed to also fit with components of the delivery system 10, can securethe delivery system handle portion 16 with the tray assembly 500.Likewise, the securing tray 508 is movable to the second main tray 504by one or more straps 518 (one shown) so that the securing tray can befolded over and fit against a part of the second main tray 504 forholding part of the catheter portion 12 and deployment portion 14 of thedelivery system 10 in place within the tray assembly 500. Preferably,each of the securing trays 506 and 508 include edges that are sized tobe tightly fitted within edges of the first and second main trays 502and 504, respectively, as known, in order for the securing trays 506 and508 to maintain their respective securing positions to the first andsecond main trays 502 and 504. Such fitting can include a snap-type fit,as known, for connected of the two, or the corresponding edges can beheat sealed, bonded, or otherwise connected to create a packageddelivery system.

With respect to the securing tray 508, in particular, a furtherfunctionality is preferably provided. That is, the securing tray 508also can be used to effectively close a saline bath area 520 that ispreferably formed into the second main tray 504 along the portionthereof that is designed to support the deployment portion 14 of thedelivery system 10, at least. The bath area 520 can be formed in thesecond main tray 504 and can be filled with cold saline solution, assuch solutions are well known for this purpose, which solution is usedduring a loading process of a tissue heart valve. The second main tray504 is also shown with a snap-fit holding element 522 that, like thesecuring trays 506 and 508 is attached by a strap 524 so that theholding element 522 can be folded over the second main tray 504 forsecuring a portion of the catheter portion 12 of the delivery system 10in place. This feature is of particular advantage during a tissue valveloading process, as described below, for holding the catheter portion 12in place while collapsing a metal frame tissue valve onto the plunger 22of the deployment portion 14 of a delivery system 10 in accordance withthe present invention.

FIG. 12 illustrates that first and second main trays 502 and 504 areeach of an elongate shape themselves and can be arranged end-to-end witheach of the securing trays 506 and 508 positioned over and preferablysnap-fit in place along with the holding feature 522. This is apreferable storage and/or shipping configuration of the tray assembly500 of the present invention. By loading the delivery system 10 into thetray assembly in this configuration, bending of the catheter portion 12is avoided. Conventional packages for such elongate catheter devicesbend the catheter portions thereof in a U-shape, which can cause a setof a curve within the catheter tubing over time. The configuration aboveavoids any such concern.

The first and second main trays 502 and 504 are also preferablyoperatively connected together so that they can be arranged end-to-end,as shown in FIGS. 11 and 12, and side-to-side, as illustrated in FIG.13. To do this, a hinge 526 can be provided, as shown, that includes apintle and bearing surface arrangement, as such can be formed into therespective corners of the first and second main trays 502 and 504.Preferably, the corresponding formed elements of such a hinge aresnap-fit to keep the hinge from coming apart. To facilitate rotationalmovement around the hinge 526, the second main tray 504 is provided witha thin portion 528 that easily slides beneath the corner of the firstmain tray 502 so that a substantial side-by-side arrangement of thefirst and second main trays 502 and 504 can be configured by simplyrotating the second main tray 504 about the hinge 526 while the firstmain tray 502 is stationary. Of course, either or both trays can just aseasily be rotated to one another.

FIG. 13 illustrates the tray assembly in the rotated side-by-sideconfiguration. Thin portion 528 of second main tray 504 is beneath aportion of the first main tray 502. In this configuration, the catheterportion 12 of a delivery system that is packaged within the trayassembly 500 is bent in a substantial U-shape. Moreover, the bath area520 of the second main tray 504 is now located substantially adjacent tothe proximal handle portion 16 of the delivery system. This position isadvantageous for loading a tissue valve to the deployment portion 14 ofthe delivery system in that the elements of the handle control portion16, as described above, can easily be manipulated while the tissue valveis prepared and loaded to the nearby deployment portion. In this regard,both micro-actuation and macro-actuation control of the sheath 20 at thedistal end of such a delivery system 10 can be effected during theloading process.

By this packaging tray assembly, a first configuration is provided wherethe delivery system can be supported by the first and second main trayswith the elongate catheter of the delivery system arranged to extendlinearly from the first main tray to the second main tray. The packagingtray assembly also provides for a second configuration where thedelivery system can be supported by the first and second main trays withthe elongate catheter of the delivery system turned back in a U-shapedmanner with the deployment portion of the delivery system positioned tothe side of the control handle portion of the delivery system.

Another aspect of the present invention relates to the selective surfacemodification of surface of a delivery system according to the presentinvention. It is a purpose of the utilization of such selective surfacemodifications to improve the force that is necessary for insertion intoand through an introducer, for example, (need more info here) and toreduce tracking forces throughout a patient's vasculature, including inparticular, the aortic arch for a femoral artery approach to a patient'saorta.

Preferably surface modification of select delivery system surfacescomprises the coating of such select surfaces. Other surface modifyingtechniques are contemplated as well that may include treatments bycertain types of energy, chemical non-coating treatments, mechanicaltreatments, such as surface polishing, and the like. It is alsocontemplated to perform multiple coatings or other techniques togetherto one surface or selectively to distinct surfaces as effective.

In accordance with the present invention, it has been found to improvefunctionality of loading of a prosthetic aortic valve, for example, ontothe deployment portion 14 of a delivery system 10, as illustrated inFig. In this regard, it is preferable to coat the delivery systemnosecone 28 and the sheath 20 of a delivery system 10 with a hydrophiliccoating. This portion of the delivery system does not need to becontacted during the valve loading process, as described above.

1-9. (canceled) 10: A prosthetic heart valve delivery system comprising:an elongate catheter comprising a sheath and a shaft, at least a portionof the shaft residing within a lumen of the sheath, the shaft configuredto support a collapsible prosthetic heart valve, the sheath configuredto cover and uncover the collapsed prosthetic heart valve supported bythe shaft; a handle comprising a sheath actuator operatively coupled toa proximal end of the sheath; and a shaft retractor releasably coupledto a proximal end of the handle and fixedly coupled to a proximal end ofthe shaft, the sheath actuator configured to provide a controlledtranslation of the sheath relative to the shaft when the shaft retractoris coupled to the handle, the shaft retractor configured to translatethe shaft relative to the sheath when the shaft retractor is releasedfrom the handle. 11: The delivery system of claim 10, wherein the sheathactuator is configured to provide a controlled micro-adjustmenttranslation of the sheath relative to the shaft when the shaft retractoris coupled to the handle. 12: The delivery system of claim 10, whereinthe sheath actuator is configured to provide a controlledmacro-adjustment translation of the sheath relative to the shaft whenthe shaft retractor is coupled to the handle. 13: The delivery system ofclaim 10, wherein the sheath actuator is configured to provide acontrolled micro-adjustment translation and a controlledmacro-adjustment translation of the sheath relative to the shaft whenthe shaft retractor is coupled to the handle. 14: The delivery system ofclaim 10, wherein the handle further comprises a threaded memberoperatively coupled to the shaft, wherein the sheath actuator isconfigured to advance and retract along the threaded member so thattranslation of the sheath actuator along the threaded member by rotationof the sheath actuator translates the sheath relative to the shaft in acontrolled micro-adjustment manner, wherein the sheath actuator isreleasable from the threaded member so that the sheath actuator can betranslated along the threaded member without rotation of the sheathactuator in a controlled macro-adjustment manner. 15: The deliverysystem of claim 10, wherein the handle further comprises a threadedmember operatively coupled to the shaft, wherein the shaft retractor isreleasably coupled to the threaded member, wherein the shaft retractorincludes a first configuration wherein the shaft retractor is coupled tothe threaded member such that the shaft does not move relative to thethreaded member and a second configuration wherein the shaft retractoris released from the threaded member such that the shaft can be movedrelative to the threaded member. 16: The delivery system of claim 10,wherein the handle further comprises a threaded member operativelycoupled to the shaft, wherein the shaft retractor includes a firstconfiguration wherein the shaft retractor is coupled to the threadedmember such that the shaft does not move relative to the threaded memberand a second configuration wherein the shaft retractor is released fromthe threaded member such that the shaft can be moved relative to thethreaded member, wherein the shaft retractor in the first configuration,the shaft and the threaded member are part of a stationary portion ofthe delivery system, wherein a relatively movable portion of thedelivery system is movable with respect to the stationary portion, andwherein the relatively movable portion comprises the sheath and sheathactuator, wherein the sheath actuator is configured to advance andretract along the threaded member. 17: A prosthetic heart valve deliverysystem comprising: an elongate catheter comprising a sheath and a shaft,at least a portion of the shaft residing within a lumen of the sheath,wherein the shaft is configured to support a collapsible prostheticheart valve, wherein the sheath is configured to cover and uncover thecollapsed prosthetic heart valve supported by the shaft; a handlecomprising a threaded member and a sheath actuator, the threaded memberoperatively coupled to the shaft, the sheath actuator operativelycoupled to a proximal end of the sheath, wherein the sheath actuator isconfigured to advance and retract along the threaded member so thattranslation of the sheath actuator along the threaded member by rotationof the sheath actuator translates the sheath relative to the shaft in acontrolled micro-adjustment manner, wherein the sheath actuator isreleasable from the threaded member so that the sheath actuator can betranslated along the threaded member without rotation of the sheathactuator in a controlled macro-adjustment manner; and a shaft retractorreleasably coupled to the threaded member and fixedly coupled to aproximal end of the shaft, wherein the shaft retractor includes a firstconfiguration wherein the shaft retractor is coupled to the threadedmember such that the shaft does not move relative to the threaded memberand a second configuration wherein the shaft retractor is released fromthe threaded member such that the shaft can be moved relative to thethreaded member, wherein the sheath actuator is configured to provide acontrolled translation of the sheath relative to the shaft when theshaft retractor is coupled to the threaded member, wherein the shaftretractor is configured to translate the shaft relative to the sheathwhen the shaft retractor is released from the threaded member.